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ARCHIMEDES

Towards evidence based medicine for paediatriciansEdited by Bob Phillips. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Arch Dis Child 2004;89:286290. doi: 10.1136/adc.2003.048280

In order to give the best care to patients and families,paediatricians need to integrate the highest qualityscientific evidence with clinical expertise and the opinionsof the family. 1 Archimedes seeks to assist practising cliniciansby providing evidence based answers to common questions which are not at the forefront of research but are at the coreof practice. In doing this, we are adapting a format which hasbeen successfully developed by Kevin Macaway-Jones andthe group at the Emergency Medicine JournalBestBets.

A word of warning. The topic summaries are not systematicreviews, through they are as exhaustive as a practisingclinician can produce. They make no attempt to statisticallyaggregate the data, nor search the grey, unpublished

literature. What Archimedes offers are practical, best evidencebased answers to practical, clinical questions.

The format of Archimedes may be familiar. A description of the clinical setting is followed by a structured clinicalquestion. (These aid in focusing the mind, assisting search-ing, 2 and gaining answers. 3 ) A brief report of the search usedfollowsthis has been performed in a hierarchical way, tosearch for the best quality evidence to answer the question. 4

A table provides a summary of the evidence and key points of the critical appraisal. For further information on criticalappraisal, and the measures of effect (such as number neededto treat, NNT) books by Sackett 5 and Moyer 6 may help. Topull the information together, a commentary is provided. Butto make it all much more accessible, a box provides the

clinical bottom lines.The electronic edition of this journal contains extrainformation to each of the published Archimedes topics. Thepapers summarised in tables are linked, by an interactivetable, to more detailed appraisals of the studies. Updates topreviously published topics will be linked to the originalarticle when they are available. This month an electronicupdate on Inhaled steroids in the treatment of mild tomoderate persistent asthma in children once or twice dailyadministration has been published.

Readers wishing to submit their own questionswith bestevidence answersare encouraged to review those alreadyproposed at www.bestbets.org. If your question still hasntbeen answered, feel free to submit your summary accordingto the Instructions for Authors at www.archdischild.com.Three topics are covered in this issue of the journal.N Should we screen every child with otitis media with

effusion for allergic rhinitis?N Should we treat infantile seborrhoeic dermatitis with

topical antifungals or topical steroids?N Is routine EEG helpful in the management of complex

febrile seizures?

Bob Phillips, Evidence-based On Call, Centre for Evidence-based Medicine, University Dept of Psychiatry, WarnefordHospital, Headington OX3 7JX, UK;[email protected]

Beyond the evidenceIt would be a wonderful thing if every treatment we used hadbeen tested in trials where the populations matched oursexactly. Sadly, this isnt the case. In paediatrics, the evidence we have may be in the wrong population: including lots of adults or children of the wrong age. Or the outcomesrecorded may only be surrogates, rather than clinically important changes. In order to use the best evidence inpractice, we need to consider how far we can take the resultsbeyond the evidence.

Fortunately, as with many aspects of critical appraisal,there are guides as to how to think about the issues related tousing studies which dont directly apply to our population.1 It is suggested that first, we should ask if there are biologicaldifferences between the populations. For example, does thesame process produce cradle cap in babies as seborrhoeicdermatitis in adults? Here it may be relevant to look at pathological data, or compare the results of studies of alternative treatments in the populations under suspicion.

Second, it is appropriate to consider whether differences inpsychology, social setting, or economy will stop the databeing applicable. When we turn to psychological differencesit is clearly inappropriate to use a cognitive-behaviouraltherapy in infants, but how should we appraise a trial whichshows improved quality of life in adults? If there aresignificant differences in economic or social setting, it may strongly affect the familys adherence to a therapy.

If the treatment seems to be feasible and sensible, we aresuggested to address issues of risk and co-morbidity. If COX-2 inhibitors do reduce the chance of gastrointestinalbleeding,2 should we be using them in children with juvenilearthritis? We need to know the basic risk of GI bleeding inour population, in order to estimate the benefit they may gainfrom using the new drugs.

The last issue to consider is that of outcomes. What is theinformation on side effects? Is there any information about adverse events in children? Are the outcomes we are givendirectly relevant to our patients (such as improved function in JIA) or surrogate outcomes (such as reduced serum CRP)?

As with everything in evidence based practice, theseguides dont give you the rules to act on, but tools to think through. When considering if you can go beyond theevidence, look at biological and psychological differences,

consider the inherent risk and co-morbidities, and examineall the outcomes closely. Then youll have a better idea of how far you can apply best evidence to your practice.

References1 Dans A,Mcallister F, Dans A,et al . Applying results to individual patients.

Chapter 23. In: Guyatt & Rennie, eds.Users guides to the medical literature . American Medical Association, 2002.

2 Deeks JJ,Smith LA, Bradley MD. Efficacy, tolerability, and upper gastrointestinal safety of celecoxib for treatment of osteoarthritis andrheumatoid arthritis: systematic review of randomised controlled trials.BMJ 2002;325:619.

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REFERENCES1 Moyer VA,Ellior EJ. Preface. In: Moyer VA, Elliott EJ, Davis RL,et al , eds.

Evidence based pediatrics and child health, Issue 1. London: BMJ Books, 2000.2 Richardson WS,Wilson MC, Nishikawa J,et al . The well-built clinical

question: a key to evidence-based decisions.ACP J Club 1995;123:A1213.3 Bergus GR,Randall CS, Sinift SD,et al . Does the structure of clinical questions

affect the outcome of curbside consultations with specialty colleagues? ArchFam Med 2000;9:5417.

4 http://cebm.jr2.ox.ac.uk/docs/levels.htm (accessed July 2002).5 Sackett DL,Starus S, Richardson WS,et al . Evidence-based medicine. How to

practice and teach EBM. San Diego: Harcourt-Brace, 2000.6 Moyer VA,Elliott EJ, Davis RL,et al , eds.Evidence based pediatrics and child

health, Issue 1. London: BMJ Books, 2000.

Additional information on each of the topics isavailable on theADC website (www.archdischild.com/supplemental)

Should we screen every child withotitis media with effusion for allergic rhinitis?Report by

S Miceli Sopo,Department of Pediatrics, Catholic University of Rome, Italy; [email protected] G Zorzi,Department of Pediatrics, Catholic University of Rome, Italy M jr Calvani,Department of Paediatrics, SanCamillo De Lellis Hospital, Rome, Italy doi: 10.1136/adc.2003.048041

Spiro, a 12 year old boy, was referred to the AllergyClinic of Department of Pediatrics because of otitismedia with effusion (OME) that had been presentfor the past four years. A paediatrician and an otolaryngol-

ogist advised a consultation with an allergist because they

Commentary The full text of two relevant studies 3 4 was not accessible tous (one was published in Japanese, the other in Turkish);however, the abstract furnished sufficient details for asummary evaluation of their validity and utility for ourquestion.

The studies that we examined in full text 1 2 showedmarked difference in the prevalence of AR in children withOME: 16.3% versus 89%. Trying to explain this discrepancy, itcan be noted that the study of Alles and colleagues 2 is affectedby some methodological imperfections that seriously compro-mise its validity. It lacks a well defined control group and thestudy definitions of AR and OME are weak. For AR, neither theappearance of the symptoms after exposure to an allergen northe demonstration, necessarily, of sensitisation to an allergenthrough measurement of the specific IgE is required. Even thedefinition of OME was not strong: an unconfirmed history of OME was sufficient for enrolment. The prevalence of the AR inchildren with OME in the study of Caffarelli and colleagues 1

gives the more reliable estimates; because of the fact that theirstudy is prospective, and the authors have adopted rigorousdiagnostic criteria for both the illness studied (AR and OME),have included an adequate control population, and haveenrolled a sufficient number of children.

Table 1 Allergic rhinitis in children with otitis media

Citation Study groupStudy type (level ofevidence) Outcome Key results Comments

Caffarelliet al (1998)

172 children with OMEreferred because of symptoms to the Centrefor the Study of OME.200 healthy children ascontrols

Case-control study (level 2b)

Prevalence of allergicrhinitis

16.3% in children with OME; 5.5% incontrols. OR=3.34(95%CI 1.6 to 6.3),p, 0.001

Well defined and rigorousdiagnostic criteria of OMEand AR. Presence of anadequate random controlpopulation. Sufficient sample size

Kayhanet al

(2002)

22 children with OME;

21 children with nosymptoms of otolaryngologicaldisease as controls

Case-control study

(level 2b)

Prevalence of allergic

rhinitis

23% in children with

OME; 4.8% in controls.OR= 5.9 (95% CI 0.6to 55.4), p. 0.05

Good quality of definition

of diagnosis of OME and AR. Small numbers. Articlein Turkish

Alleset al (2001)

209 children with OME Case series (level 4) Prevalence of atopy andallergic disease (rhinitis,asthma, eczema)

Prevalence of AR= 89%

Poor quality of definition of diagnosis of OME and AR.Lack of a control population

Ogawa(2002)

185 children with OME Case series (level 4) Description of variousoutcomes (allergic andnon-allergic)

Prevalence of AR= 14%

Unknown quality of definitionof diagnosis of OME and AR.Lack of a control population. Article in Japanese

believed that Spiro had OME because he suffered fromallergic rhinitis (AR). Should we look for AR in every child with OME?

Structured clinical questionDo children with OME [population] have an increased risk of AR [outcome] than children without OME [comparison]?

Search strategy and outcome

Our search strategy (extended to 2 August 2003) was:N Cochrane Database of Systematic Reviews using: otitismedia AND allergy ; 13 references (none relevant).

N Medline, via Pubmed: otitis media with effusion ANDallergic rhinitis ; 62 references (four relevant).

See table 1.

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The prospective design of the study reduces the recall biasand the possibility of differences in the management of thepatients. A rigorous definition of allergic rhinitis allowsavoiding its overdiagnosis and the inclusion of patients withnon-allergic rhinitis. OME was defined prospectively withtympanometry performed on all the patients (to define casesand controls). The presence of a control group allows us toquantify the parameter we consider the most interesting that is, the difference (absolute risk increase) in theprevalence of the allergic rhinitis between the children with

OME and the ones without. And finally, the presence of alarge sample makes the estimate of the absolute risk increasemore accurate, tightening its confidence interval.

The duration of OME is an important variable in manage-ment decisions: studies of children in day care note that many will have brief periods of time (one or several days) with OMEthat spontaneously clears; in contrast other children will haveOME for months. Only for the latter children would anyintervention have the potential to be useful.

However, the studies on the efficacy of antiallergic therapyin the treatment of children with OME are few, methodolo-gically weak, and inconclusive. Irrespective of the theore-tical mechanism, the relation between allergy and otitismedia with effusion will remain controversial until wellcontrolled clinical studies are conducted documenting that inselect populations antiallergy therapy is efficacious inpreventing or limiting the duration of otitis media witheffusion .5 Today, the situation is unchanged.

REFERENCES1 Caffarelli C,Savini E, Giordano S,et al . Atopy in children with otitis media

with effusion.Clin Exp Allergy 1998;28:5916.2 Alles R,Parikh A, Hawk L,et al . The prevalence of atopic disorders in children

with chronic otitis media with effusion.Pediatr Allergy Immunol 2001;12:1026.

3 Ogawa H. Otitis media with effusion: a study of 346 cases in an outpatient clinic.Nippon Jibiinkoka Gakkai Kaiho 2002;105:86372.

4 Kayhan FT,Ergez E, Hatipoglu A,et al . The incidence of allergic rhinitis inchildren with otitis media with effusion.Kulak Burun Bogaz Ihtis Derg 2002;9:1847.

5 Bernstein JM.Role of allergy in Eustachian tube blockage and otitis media witheffusion: a review.Otolaryngol Head Neck Surg 1996;114:5628.

CLINICAL BOTTOM LINEN The prevalence of allergic rhinitis is significantly higher in

children with otitis media with effusion (16.3%) than inhealthy controls (5.5%).

N Allergologic screening is not necessary in children withOME as all children with allergic rhinitis present all or some of the characteristic symptoms.

N Treatment for allergic rhinitis has not been shown toimprove otitis media with effusion.

N If there are signs or symptoms of allergic rhinitis, further evaluation is justified, because of the potential benefit of treatment for the rhinitis.

A mother brings her 2 month old child to you withunsightly seborrhoeic dermatitis on his/her scalp. Youprescribe 1% hydrocortisone but the mother expressesher unhappiness at using steroids. You remember that thedermatologists at your hospital like to use an antifungalcream and you decide to find out more.

Structured clinical questionIn infants with seborrhoeic dermatitis [patient] is there anyadvantage to using topical antifungals [intervention] over

steroids [comparison] to cure seborrhoeic dermatitis of thescalp and prevent recurrences [outcome]?

Search strategy Primary sourceMedline 1966 2003 (Ovid).

Subject heading seborrhoeic dermatitis + subheadingstherapy AND drug therapy ; 556 articles produced andsorted manually: 5 relevant; see table 2.

Secondary sourceCochrane database and Best Bets website under keywordseborrhoeic . No further papers.

Commentary Seborrhoeic dermatitis is a common benign condition of childhood. Often the most appropriate treatment is to donothing; however, children with scalp seborrhoeic dermatitisstill make regular presentations to paediatric outpatientclinics with disease burden enough to warrant treatment.

The link between the excessive presence of Pityrosporumovale yeast to seborrhoeic dermatitis is well documented inthe literature and it is intuitive that using a pityrosporicidalagent would not only treat the condition, but help preventrecurrences. Both fungicides and steroids have been shown tobe effective in the treatment of seborrhoeic dermatitis whencompared to placebo.

Five trials of good quality were found directly comparingtopical steroids with topical fungicides. At one month of treatment, four of the trials showed good effectiveness of

both treatments and no significant differences between them.One trial (Ortonne et al) showed a very slight improvement inthe ketoconazole group over the steroid group.

The trials reviewed are all on adults as there are nocomparable trials in infants. However, the extrapolation tothis age group is viable as the disease is similar. Only onepaper (Zeharia et al), with a specifically paediatric age groupcould be found and the quality was too low to allowmeaningful analysis.

The three studies which also looked at the recurrence rateshowed similar results in two and a slight advantage in usingketoconazole in one. Two trials noted low and similarincidence of side effects and one (Ortonne et al) showed amuch better tolerance of the antifungal over the steroid.

There is no clear consensus on treatment regimen.However, a four week course was shown to be effective infour of the trials using a once or twice a day regimen.

There has been a paper published on the safety of ketoconazole in infants (Brodell et al) which showed that acourse of ketoconazole twice a week for four weeks producedno detectable serum ketoconazole levels and no change in LFTs.

CLINICAL BOTTOM LINEN Ketoconazole is at least as effective at treating seborrhoeic

dermatitis as steroid creams and may be better at preventing recurrences, providing a good alternative tousing steroid creams in infants.

Should we treat infantileseborrhoeic dermatitis withtopical antifungals or topicalsteroids?Report by S Cohen,Royal London Hospital, UK; [email protected] doi: 10.1136/adc.2003.048058

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REFERENCESPari T,Pulimood S, Jacob M,et al . Randomised double blind controlled trial of 2%ketoconazole cream versus 0.05% clobetasol 17-butyrate cream in seborrhoeicdermatitis.J Eur Acad Dermatol Venereol 1988;10:8990.Ortonne JP, Lacour JP, Vitetta A,et al . Comparative study of ketoconazole 2%foaming gel and betamethasone dipropionate 0.05% lotion in the treatment of seborrhoeic dermatitis in adults.Dermatology 1992;184:27580.Katsambas A,Antoniou C, Frangouli E,et al . A double-blind trial of treatment of seborrhoeic dermatitis with 2% ketoconazole cream compared with 1% hydro-cortisone cream.Br J Dermatol 1989;121:3537.

Stratigos JD,Antoniou C, Katsambas A,et al . Ketoconazole 2% cream versushydrocortisone 1% cream in the treatment of seborrhoeic dermatitis. A double-blind comparative study.J Am Acad Dermatol 1988;19(5 pt 1):8503.Faergemann J. Seborrhoeic dermatitis and Pityosporum obiculare: treatment of seborrhoeic dermatitis of the scalp with miconazole-hydrocortisone (Daktacort),miconazole and hydrocortisone.Br J Dermatol 1986;114:695700.Zeharia A,Mimouni M, Fogel D. Treatment with bifonazole shampoo for scalp seborrhoea in infants and young children.Paediatr Dermatol 1996;13:1513.Brodell R,Patel S, Venglarick J,et al . The safety of ketoconazole shampoo for infantile seborrheic dermatitis.Pediatr Dermatol 1988;15:4067.

Table 2 Steroids versus antifungals in the treatment of seborrhoeic dermatitis

Citation Study groupStudy type (levelof evidence) Outcome Key results Comments

Pariet al (1988)

36 adult patients with faceand trunk seborrhoeicdermatitis. Randomised to2% ketoconazole v 0.05%clobetasol BD for 4 weeks

Randomised doubleblind trial (level 1b)

Resolution at 4 weeks Effective remission in bothgroups (ketoconazole 64.7%,clobetasone 63.2%). ARR2 0.015 95% CI0.33 to 0.30

Not applied to scalp(coal tar shampoo givenif scalp affected). Nocomparison of patient characteristics. Smallnumbers in trial

Recurrence at 3 months

Recurrence rates 30%ketoconazole and 50% steroid. ARR 0.180 95% CI2 0.13to 0.49

Ortonneet al (1992)

62 adult patients with scalpseborrhoeic dermatitis andother locations. Randomisedto 2% ketoconazole foaminggel or betamethasone inreducing course over 4 months.

Randomised singleblind trial (level 1b)

Resolution at 1and 4 months

Effective remission in bothgroups at 1 month (ketoconazole90%, betamethasone 73%). ARR0.226 95% CI2 0.44 to 0.90

Adverse effects greater in betamethasone group(52% v 16%) NNT 3

At 4 months ketoconazole 89%,betamethasone 62%. ARR 0.29095% CI 0.09 to 0.49

Recurrence Recurrence rates similar 70%ketoconazole and 86%betamethasone. ARR 0.15395% CI2 0.08 to 0.38

Stratigoset al (1988)

78 adult patients withseborrhoeic dermatitis.Randomised to 2%ketoconazole cream or

1% hydrocortisone creamOD for 4 weeks


Response of seborrhoeicdermatitis at 2 and 4 weeks

At 4 weeks effective remissionin both groups (ketoconazole81%, hydrocortisone 94%). ARR2 0.139 95% CI2 0.29 to 0.01

2 week result similar.Low incidence of sideeffects in both groups.

Faergemann(1986)

70 adult patients with scalpseborrhoeic dermatitis.Randomised to 2%miconazole, 1%hydrocortisone or Daktacort combination OD for 3 weeksand then if no cure for afurther 3 weeks


Resolution at 3 and 6 weeks

At 3 weeks poor remission inall groups (miconazole 33%,hydrocortisone 33%). ARR2 0.116 95% CI2 0.15 to2 0.01

No details of randomisation.Interesting look at steroid-fungicidecombination

Recurrence after using same solutionin patients achievingremission twicemonthly for 3 months

Risk of recurrence higher inmiconazole group(hydrocortisone 82%,miconazole 33%). ARR 0.45295% CI 0.22 to 0.67

Katsambaset al (1989)

50 adult patients withseborrhoeic dermatitis.Randomised to 2%ketoconazole cream or

1% hydrocortisone creamBD for 4 weeks


Response at 4 weeks

Effective response in bothgroups (ketoconazole 83%,hydrocortisone 96%). ARR2 0.128 95% CI2 0.30 to

0.04

Low incidence of sideeffects in both groups. Nodetails of randomisation.No comparison of

patient characteristics

Zehariaet al (1995)

36 children from 1 month to10 years (mean 17 months) with scalp seborrhoeicdermatitis treated withbifonazole 1% shampoo3 times a week for 4 weeks

Poor quality cohort study (level 4)

Resolution at 4 weeks

71% patients cured at 4 weeks No randomisation or placebo comparator.Experimenters assumedin conclusion that the high rate of curesmakes analysisstraightforwardand self-evident

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Is routine EEG helpful in themanagement of complex febrileseizures?Report by E Cuestas,Hospital Privado, Co rdoba, Argentina ;[email protected]

doi: 10.1136/adc.2003.048447

A previously healthy 16 month old girl attends with thefirst episode of a complex febrile seizure (prolongedmore than 15 minutes). She is neurologically normal,and examination reveals otitis media as the source of herfever. According to local protocol, her evaluation includes anEEG. One cannot but wonder as to the value of this routinepractice.

Structured clinical questionIn a 16 month old neurologically healthy girl [patient] withthe first episode of a complex febrile seizure [risk factor] what is the probability of abnormalities after postictal EEG[outcome]?

Search strategy and outcomeSecondary sources nil.

Search strategy (febrile, seizures, complex) [MeSH] AND EEG.

Search results 68 individual articles found, one relevant.See table 3.

Commentary A febrile seizure is defined as a seizure accompanied by fever without central nervous system infection. Complex febrileseizures, also called atypical or complicated, were defined asfocal, prolonged more than 15 minutes, or repetitive.

The purpose of an EEG in the evaluation of complex febrileseizures is to help identify the nature of underlying acute orremote cerebral pathology and predict the risk of futureafebrile seizures; no published study has shown that earlyEEG after a first episode of febrile seizures in postictalneurologically normal children will predict the occurrence of afebrile seizures.

Studies that investigate the relations of signs or symptoms with EEG abnormalities or between clinical subgroups of

complex febrile seizures, for example, focal, prolonged orrecurrent, have not been found.

Only one small and non-independently validated descrip-tive report with 33 patients has specifically answered thequestion (Maytal et al). This study addressed the value of anearly postictal sleep EEG to detect the prevalence of abnormalities in neurologically normal children with thefirst complex febrile seizures, up to one week after theseizure. The study was retrospective and did not indicate whether EEGs were repeated over a follow up period. Twentyfour patients were qualified as complex cases based on onefactor (prolonged in nine, repetitive in 13, and focal in two).Nine other patients had two complex factors (in six theseizures were long and repetitive, in two focal and repetitive,and in one the seizures were long, focal, and repetitive), which reduced the actual useful number of patients compar-able to our patients in a clinical scenario.

The study was uncontrolled and included only neurologi-cally normal children. Maytal and colleagues made no dif-ferences between complex febrile seizure clinical subgroups. An important number of patients experienced prior febrileseizures; not all patients were therefore assembled at acommon point in the course of the disease.

The rate of abnormalities after an early postictal EEG inthese patients was low and similar to the reported rate of abnormalities in children with simple febrile seizures, a factthat could be confirmed on a larger number of patients.

EEG should be considered in all children with complexfebrile seizures who recur with afebrile convulsions, or inthose children who recur with febrile seizures and exhibitdevelopmental delays or abnormal neurological signs andsymptoms.

REFERENCESMaytal J,Steel R, Eviatar L,et al . The value of early postictal EEG in children withcomplex febrile seizures.Epilepsia 2000;41:21921.Hanley JA,Lippman-Hand A. If nothing goes wrong, is everything all right ?Interpreting zero numerators.JAMA 1983;249:17435.

Table 3 EEG in the management of complex febrile seizures

Citation Study group Study type (level of evidence) Outcome Key results Comments

Maytalet al (2000) 33 patients with complex febrileseizures. Mean age 17.8 months.Neurologically normal children

Retrospective chart review (level 4)

EEG 100% normal(95% CI 89.6100)

Thirteen (39%) patientsexperienced prior febrileseizures

CLINICAL BOTTOM LINEN Abnormal EEG was uncommon in children with complex

febrile seizures (95% probability less than 8.6%).N The current local practice of EEG in neurologically normal

children with complex febrile seizures does not appear tobe evidence based. There is some limited evidence to

suggest that it may not be useful.

An update toInhaled steroids in the treatment of mildto moderate persistent asthma in children: once or twicedaily administration? ( Arch Dis Child 2002;87 :41516)has been posted online at http://www.archdischild.com/supplemental.

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E Cuestas

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(370 articles)Child and adolescent psychiatry (pa edatrics) (267 articles)Asthma

(2037 articles)Child he alth (213 articles)Epilepsy an d seizures

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Arch Dis Child 2004 Cuestas 290

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Transcript of Arch Dis Child 2004 Cuestas 290